Registration Dossier
Registration Dossier
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EC number: 201-132-3 | CAS number: 78-67-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1996
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- no data
- Author:
- Elf Atochem
- Year:
- 1 996
- Bibliographic source:
- cited in OECD SIDS Final 08/02
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was conducted before implementation of LLNA-method
Test material
- Reference substance name:
- Reference substance 001
- Details on test material:
- - purity: 99.2 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- day 1 / 7 days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 500 mg
- Day(s)/duration:
- day 8 / 48 h
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 500 mg
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 12 days
- Control group: treatment with vehicle only
- Site: intradermal injection in the dorsal region between the shoulders, topical application to the same site
- Frequency of applications: day 1 and day 8
- Duration: 12 days
- Concentrations: 0.1 % in vehicle for intradermal injection and 500 mg undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 24 h
- Exposure period: 24 h
- Control group: treatment with vehicle only
- Concentrations: 500 mg undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after challenge application
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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